A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Firmonertinib

This is an open-label phase 2 study to evaluate the safety, tolerability and preliminary anti-tumour activity of ABSK043 in combination with Firmonertinib in patients with Epidermal Growth Factor Receptor-mutated (EGFRm+) locally advanced or metastatic NSCLC.

Trial Details

NCT ID
NCT06668103
Phase
PHASE2
Sponsor
Abbisko Therapeutics Co, Ltd
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • ABSK043 in combination with Firmonertinib
Locations (sample)
  • Hefei, Anhui, China|31.86389,117.28083
  • Harbin, Heilongjiang, China|45.75,126.65
  • Wuhan, Hubei, China|30.58333,114.26667
  • Changchun, Jilin, China|43.88,125.32278
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • Histologically or cytologically documented locally advanced or metastatic NSCLC
  • At least 1 measurable lesion as assessed by Investigator as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
  • Inclusion Criteria Specific to Dose Escalation cohort and Dose Confirmation Cohort:Must has disease progression following treatment with EGFR-TKI i…
  • Adequate bone marrow reserve and organ function based on local laboratory data .

For full eligibility, visit ClinicalTrials.gov.

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